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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Vascular System (Circulation), Impaired (2572)
Event Date 04/25/2012
Event Type  Injury  
Manufacturer Narrative
This report is a follow up report to mfr number 9616099-2016-00375 that was submitted under the previous complaint handling software system. The information has been duplicated from the first report with additional information added. As reported, the patient underwent placement of optease inferior vena cava (ivc) filter on approximately (b)(6) 2012. Per the medical records, the filter was placed due to chronic venous embolism, thrombosis of deep vessels of proximal lower extremity, and abdominal wall hematoma precluding coumadin therapy. The index procedure was reported to be an uncomplicated placement of a retrievable optease filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter embedded in wall of the ivc and is unable to be retrieved. As a direct and proximate result of these malfunctions, the patient suffered life threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The medical records indicate that the patient has experienced clotting in the filter that could not be cleared and poor blood circulation in the lower extremities. The filter remains implanted; thus, unavailable for analysis. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Occlusive thrombosis within the filter do not represent a device malfunction. The predominant concern for embedding with in the wall of the ivc is the development of endothelialization. Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells. This is the normal process whereby the body heals and recovers from invasive procedures. Endothelialization has been shown to occur in as short a period as 12 days. Poor peripheral circulation does not represent a device malfunction and may be related to underlying patient related issues. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
Event Description
As reported in the legal brief, the patient underwent placement of optease vena cava filter on or about (b)(6) 2012. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter embedded in wall of the ivc and is unable to be retrieved. As a direct and proximate result of these malfunctions, the patient suffered life threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The following additional information received per the medical records indicates the filter was placed initially due to chronic venous embolism, thrombosis of deep vessels of proximal lower extremity, and abdominal wall hematoma precluding coumadin therapy. The medical records indicate that the patient has experienced clotting in the filter that could not be cleared and poor blood circulation in the lower extremities. The index procedure was reported to be an uncomplicated placement of a retrievable optease filter.
 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7136582
MDR Text Key95450324
Report Number1016427-2017-00888
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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